Guidelines for the ethical review of laboratory animal welfare People’s Republic of China National Standard GB/T 35892‐2018 [Issued 6 February 2018 Effective from 1 September 2018]

ABSTRACT These Chinese National Guidelines (GB/T 35892‐20181) were issued February 06, 2018 and became effective September 01, 2018. The authors recognized the urgent need for an authentic English translation to inform the international community of the compliance requirements in China. It was appreciated that the final translation must reflect the specialist understanding of those working under the Guideline whilst remaining faithful to the meaning of the original Chinese text. A three‐step translation process was therefore determined. Step 1: A professional interpretation service (KL Communications, UK) was commissioned to prepare a literal translation of the Chinese text. Supportive documents were provided which explained specialist terminology. This translation was checked by two bilingual experts. Step 2: A workshop was held in Nanjing in May 2019 to which were invited experts in laboratory animal welfare and ethical use. These included international native English‐speaking and Chinese‐speaking delegates. The delegates worked in multi‐lingual teams to review sections of the literal translation ahead of the workshop, and to agree an authentic interpretation during the workshop. Step 3: Following the workshop, three bilingual experts (two native Chinese speakers and one native English speaker) reviewed the entire document to ensure consistency of terminology and general accuracy. This document is thus not a “literal translation” but an “accurate interpretation” of the original text. Any challenge of work being performed under these Guidelines should rely on the Chinese text in the first place. However, this translation may be used as mitigating evidence, especially where those performing the work are non‐Chinese speakers.


| Environmental Enrichment
The optimization and enrichment of living conditions for laboratory animals (for instance, housing standards, cages, toys, level of comfort, foraging opportunities, ability to carry out natural behaviors etc.).

| Ethical Review
In accordance with the principles and standards of laboratory animal welfare and ethics, an examination and assessment expressly conducted on the necessity, rationality and compliance with relevant regulations of the use of laboratory animals.

| Humane Endpoint
An endpoint which is applied at the earliest possible stage when an animal is exhibiting pain or suffering during the course of the experiment, when it has become clear that the experimental objectives have been met, or that they cannot be met.

| Euthanasia
A method of humanely ending the life of an animal causing peaceful and rapid death while, to the greatest extent possible, reducing or eliminating the animal's fear and suffering.

| The principles of the 3Rs
The principles of Replacement, Reduction and Refinement in the use of laboratory animals.

| Replacement
Methods which replace animals of a higher life form with those of a lower life form, or avoid the use of animals and employ alternative methods to achieve the same objectives as experiments which use animals.

| Reduction
Methods which minimize the number of animals used per experiment to obtain the necessary data that support the scientific objectives.

| Refinement
When laboratory animals must be used, the minimization as far as possible of the frequency of use of inhumane methods or of the degree of harm caused.

| Care of laboratory animals
The effective care given to laboratory animals by humans to safeguard their welfare and interests and to avoid causing them unnecessary harm.

| The five freedoms
Through the promotion of animal welfare, ensuring for animals the Five Freedoms or Five Rights to enjoy comfort, good health, and psychological well-being, including: a. Freedom from thirst and hunger-by ensuring animals have access to fresh water and food to maintain their health and vitality.
b. Freedom from discomfort-by providing animals a comfortable living environment. c. Freedom from pain, harm and disease-by putting in place preventative care, and diagnosing and treating animals in a timely manner.
d. Freedom to carry out most natural behavior-by providing sufficient space, appropriate facilities, and company of the animal's own kind. e. Freedom from fear and distress-by ensuring good conditions and handling that will not cause mental distress or suffering to the animals.

| Establishment of the review body
4.1.1 According to particular areas of management authority, review bodies may be established at different administrative levels.
The review body may belong to a local/regional Laboratory Animal Welfare and Ethical Review Administration or to an individual institution. Administrations or institutions are responsible at their respective levels for establishing their review bodies and appointing members.
4.1.2 The review body is a specialized organization that independently conducts reviews and assessments. It may be variously designated "Animal Welfare and Ethical Review Body (AWERB)", "Institutional Animal Care and Use Committee (IACUC)" etc., but all such bodies shall have the function of review, and are hereinafter referred to as "Ethics Committees".

| General
The Ethics Committee is responsible for reviewing and overseeing the conduct of institutions within its jurisdiction on animal welfare and ethics, according to the provisions of laboratory animal related laws, regulations, and quality and technical standards.
The Ethics Committee also deals with misconduct reports and complaints.

| Membership of the Ethics Committee
4.3.1 The Ethics Committee shall comprise at least one of each of the following: laboratory animal specialist, veterinarian, laboratory animal management staff, researcher using laboratory animals, lay member of the public etc. No more than three members from the same department or branch of an institution or body may sit on the Committee at a time. The Committee will appoint one chair, and a number of vice-chairs and Committee members as the review work practically requires. 4.3.2 Ethics Committee members are appointed for 3 to 5 years.
The review body which establishes the Ethics Committee is responsible for appointments, induction and preliminary training, dismissals, and replacement of members in the case of vacancies. 4.3.3 All members of Ethics Committee must comply with the laws, regulations and standards, in order to uphold animal welfare and ethics.

| Management of the Ethics Committee
The Ethics Committee shall establish a code of conduct for the Committee, along with systems and processes for reviewing, overseeing and holding regular meetings. It shall also produce a disciplinary code as well as a professional training plan. It is responsible for reporting to the senior administrative body with oversight of the Committee. Decision making in the Committee follows majority rule.
However, comments and views expressed by the minority shall be properly recorded.

| The principle of necessity
The husbandry and use of laboratory animals as well as any program of harmful experiments must be carried out based on thorough scientific significance and necessity. Purposeless overbreeding, overuse, misuse, or unjustified killing of laboratory animals is prohibited. Duplication of experiments without purpose is prohibited.

| The principle of protection
For projects that are deemed necessary the Principles of the 3Rs shall be followed to ensure humane protection of laboratory animals. Where the scientific validity of the results of a program of experiments is not compromised, as far as possible alternative ["Replacement"] methods should be adopted, use of unnecessary numbers of animals should be reduced, and the frequency and severity of harmful use of animals should be reduced.

| The principle of welfare
As far as possible, the humane care of laboratory animals shall be assured. During the lifetime of a laboratory animal, including during transport, to the greatest possible extent it should enjoy the Five Freedoms, and its opportunity to experience a natural life, health and well-being should be guaranteed. Management and treatment of any species of laboratory animal should comply with the operating procedures stipulated for that species. Unnecessary stress, suffering and harm should be prevented or reduced, and animals should be treated in a manner which causes the least suffering.

| The principle of ethics
The lives and interests of animals shall be respected while at the same time the principles of human societal morality shall be observed. Should brutal or inhumane treatment toward animals occur, it shall be stopped. Experimental objectives, methods and procedures shall conform to moral and ethical values accepted by human society and to internationally recognized practice. Laboratory animal projects shall ensure the safety of practitioners and the public environment.

| The principle of the balance of interests
The conclusions of a welfare and ethics review of a project involving animal experiments should be arrived at responsibly, after a process that pays regard to the moral and ethical values accepted by contemporary society, and takes into account the interests of animals and humans, comprehensively and objectively assessing harms suffered by animals and the possible benefits derived as a consequence by humans.

| The principle of fairness
The review and supervision shall be independent, just, fair, scientific, democratic, and transparent; shall not breach confidentiality, and shall be free from interference by political, commercial or personal conflicts of interest.

| The principle of legality
There shall be no violation of laws and regulations or non-compliance with relevant standards with regard to project objectives, sources of animals, facilities, personnel qualifications, operating procedures, or any other aspect.

| The principle of taking account of national constraints
The welfare and ethical review shall comply with internationally recognized codes and standards, whilst being in line with China's traditional public order, moral values as well as prevailing constraints, and shall reject radical ideas and extreme practices of any kind.

| Facilities and equipment
The quality of laboratory animal housing equipment and bedding shall comply with Standard GB14925, laboratory animal welfare standards and relevant national management regulations on the care of laboratory animals. It shall be ensured that the facilities and equipment do not cause accidental injury or harm to animals.

| Use of equipment
Housing equipment shall be cleaned and disinfected regularly; bedding shall be sterilized, have minimal dust, and be replaced regularly, as well as kept clean and comfortable; drinking and feeding systems for animals shall be safe, reliable and easy to use, as well as kept clean, sanitized, and in good working condition.

| Housing space
The minimum floor-area (space) and height of cages housing any species of animals shall comply with relevant laboratory animal standards. Space shall be allocated appropriate to the husbandry requirements and physiological and behavioral needs of the animals.
It shall be ensured that each animal caged is able to freely express most natural behaviors, including turning around, standing upright, stretching limbs, lying down, walking, grooming, nesting etc.

| Breeding environment
For pregnant or parturient animals, at least 10% greater cage floor area than set out in relevant standards normal for the species should be provided, with an environment and conditions suitable for giving birth.

| Environmental enrichment
The housing environment of animals shall be enriched by the provision of suitable items that encourage activities or play, in order to promote psychological well-being. These items, however, should not harm the health and safety of animals or humans or prevent the achievement of the scientific objectives.

| Activity/play area
Nonhuman primates, dogs, pigs and other large laboratory animals that are naturally physically active and are used for breeding or involved in long-term projects shall additionally be provided with an activity area and be exercised regularly. Items for enrichment and play appropriate to the species shall be placed in the activity area to enrich the environment.

| Regular inspection
The Ethics Committee shall inspect the animal facility regularly. Site  6.6 | Animal husbandry 6.6.1 Personnel must not tease or abuse laboratory animals. Capture of animals shall be by appropriate methods, with sympathetic and gentle handling in order to avoid causing animals discomfort, fear, pain, or injury. 6.6.2 In the course of routine husbandry animals shall be regularly observed. If abnormalities are detected the cause shall be promptly investigated and the necessary actions taken to address and correct them. 6.6.3 Animal care personnel shall provide animals with sufficient feed and clean drinking water in accordance with their feeding habits and nutritional needs. Nutritional content shall comply with the requirements set out in Standard GB/T14924.2. The microbiological and physical-chemical properties of feed shall comply with the requirements set out in GB/T14924.3. 6.6.4 Newly received animals require a period of acclimatization before they are used in order for them to reach a state of physiological and behavioral stabilization. The duration of the acclimatization period depends on the mode and duration of transport, age, species, source, and anticipated use of the animals. It also depends on the differences between the environments and husbandry conditions of the place of origin and destination. 6.6.5 Animal facilities shall be able to effectively separate and isolate sick animals from healthy animals.

| Standard technical procedures
6.6.6 The specific nutritional needs of animals shall be fully met during gestation, lactation, at different stages of experiments, and during postsurgical recovery periods. 6.6.7 When an experiment requires animals' food and water intake to be restricted, full scientific justification and explanation of the necessity for fasting must be provided and submitted to the Ethics Committee for prior review and approval. 6.6.8 Laboratory animal veterinarians or personnel trained in laboratory animal veterinary care are required to monitor the parturition of dogs, pigs, and other large animals to prevent unforeseen accidents. Hand rearing, nursing, and other necessary measures shall be available to pups, piglets etc., that are not able to live independently immediately after birth. 6.6.9 For projects involving the breeding and use of genetically altered animals and spontaneous or induced mutant models in which the mutation is harmful to the animals, animals shall be monitored and special husbandry and welfare-related needs associated with the model phenotype shall be provided. 6.8.2 Based on the main safety risks at the facility, risk assessment, risk review and an emergency plan shall be developed and practice drills conducted. Examples of risks include zoonoses, toxic and hazardous chemical agents and biopreparations, radioactive hazards, allergens, specific high-risk experimental procedures, animal attacks, and resulting injuries etc. 6.8.3 In the event that a biohazard reaches a level that may cause harm, appropriate biological containment and exclusion measures shall be put in place to ensure the health of personnel and animals. Further measures shall be taken to prevent the spread of the biohazard and to ensure the safety of the public environment.
6.8.4 The review focuses on the technical approach to ensure personnel health and safety, the safety of animal experiments, and public health. 6.9 | Animal transport 6.9.1 | Transport requirements 6.9.1.1 Personnel who transport animals shall have the required laboratory animal practitioner qualifications. Measures shall be taken to reduce animal transport as much as possible. During transport, measures shall be taken to reduce animal stress responses. Housing environments and conditions before and after transport shall be as consistent as possible. After transport, experimental procedures shall not be carried out immediately, but rather, animals shall be given sufficient time to acclimatize to their new surroundings.

| Transport conditions
6.9.2.1 The shipping institution and the receiving institution shall confer and negotiate in advance, to agree an animal transport plan which includes carrier details, means of transport, transit route, transit duration, weather conditions, shipping containers, and contingency plans, in order to ensure that, for the animals, shipping occurs in the shortest, safest, and most comfortable way possible. 6.9.2.2 Implementation of the animal transport plan shall be carried out under the supervision of a laboratory animal veterinarian or laboratory animal specialist. 6.9.2.3 If an animal transport plan may have a negative impact on animal welfare, a welfare and ethical review shall be carried out. 6.9.2.4 It is not appropriate for animals to be transported while they are ill, in post-operative recovery, near parturition, or at other times when they are unfit to travel. 6.9.2.5 Transport shall also comply with the requirements on laboratory animal transport set out in the "Guidance on the Care of Laboratory Animals". 6.9.2.6 Environmental conditions during transport shall comply with the relevant requirements in Standard GB14925. The environment shall be safe and non-hazardous to animals and shall ensure that for the entire transport process animals are comfortable and can breathe freely. Transport cages shall be safe, reliable and sturdy so as to prevent animals from being injured or otherwise harmed, or from escaping, and also prevent other animals from entering. Incompatible animals should be separated to prevent them from harming each other. 6.9.2.7 If the duration of transport exceeds 6 hours, sufficient and appropriate food and water shall be supplied to animals. If the duration of transport exceeds 24 hours, bedding as well as rest breaks shall also be ensured. 6.9.3 | Import and export 6.9.3.1 Cross-border animal transport shall be carried out only when transport conditions are appropriate to the animals' physiological and behavioral needs and the animals are disease-free. Effective steps shall be taken to ensure transport cages and packaging are physically contained, so as to eliminate the possibility of cross-contamination between animals and the environment. c. Transport and handling methods and special restrictions; d. Any increase in distress due to animal training, husbandry, restraint, or experimental manipulation; e. Methods to prevent or alleviate pain, discomfort, distress, or permanent disruption to the animals' normal physical condition or physiological function, including the use of anesthesia, analgesia, and non-pharmaceutical approaches to improve comfort level, such as provision of supportive care, supplemental heat source, softer bedding, assisted feeding, etc.
f. The application of humane endpoints and final disposal of the animals, including euthanasia; g. Animal health, husbandry and care, including the provision of environmental enrichment; h. Study modifications which compromise the principles of "replacement, reduction and refinement" as well as the Five Freedoms; i. Any study components with health and safety hazards; j. Facilities, equipment, environmental conditions, and surgical procedures; k. Any change in key personnel in charge of the project and/or those responsible for conducting the experiments; l. The significance, objectives, scientific value, and societal benefit of using animals in the project (for example, harm-benefit analysis); m. Other issues concerning the project that may negatively impact on the principles of laboratory animal welfare and ethics.

| Review upon project completion
Upon project completion, the project leader shall submit a final report to the Ethics Committee on its conduct of welfare and ethics throughout the duration of the project, and undergo a retrospective review from the Ethics Committee.

| Application approval
If a project has not been found to be in breach of laws and regulations governing laboratory animal welfare and ethics, including these Standards, the Ethics Committee shall deem the project to have passed the welfare and ethics review, and produce a review report.

| Application rejection
The Ethics Committee may reject an application under one of the following conditions: a. A project that refuses or avoids ethical review; b. A project that has not provided sufficient supporting evidence or materials, or has provided incomplete or false information; c. A project that lacks objective justification and necessity for its implementation or for causing harm to animals. d. A project which allows personnel without specialized training or relevant qualifications to be involved directly in animal breeding, transport, and use, or a project which is otherwise clearly non-compliant with the principles and management requirements of laboratory animal welfare and ethics. e. A project where the work environment is unable to meet the relevant quality standards associated with animal breeding, transport, or experimentation; or where experimental conditions are unable to comply with animal welfare, occupational health and safety, public environmental safety requirements, or where there is failure to comply with animal feed, caging, and bedding standards.
f. A project that lacks operating procedures for ensuring animal welfare and ethical conduct of personnel during animal breeding, transport, and use, or a project initiated without following standard operating procedures; a project that is found to be abusing animals, causing animals to experience undue stress, harm, disease, and death; g. A project whose design is flawed and unscientific or whose implementation does not reflect the Principles of the 3Rs, the Five Freedoms, or principles of animal welfare and ethics. h. A project whose design or implementation fails to reflect humane treatment of animals or show respect for animal life, or fails to refine or perfect experimental procedures in order to minimize animal pain and distress, or to reduce the number of unnecessary animal deaths, or to use the most effective euthanasia methods to reduce the duration and severity of animal suffering.
i. A project that includes inappropriate use of anesthesia during surgery or prior to necropsy or fails to adhere to ethical and moral standards when handling live or dead animals, or uses extreme and controversial experimental procedures. j. A project that involves experimental methods or objectives that fail to adhere to national traditional moral and ethical standards, or fall outside internationally accepted norms, or which are expressly prohibited by the State, or violate current social expectations and scientific ethics. k. A project that causes animal harm without scientific merit or application nor practical benefit for humans or animals.